CITSCOPE (MODEL EXTENSIONS)— 510(k) K922144

Name: FDA 510(k) clearance K922144
Creator: U.S. Food and Drug Administration
Published: 1992-08-05

Substantially Equivalent

Citation Medical Corp.

FDA 510(k) clearance K922144 for CITSCOPE (MODEL EXTENSIONS), Substantially Equivalent on 1992-08-05. Applicant: Citation Medical Corp.. Device class: 2.

Clearance details

Applicant: Citation Medical Corp.
Product code: Code HRX
Device class: Class 2
Regulation: 21 CFR 888.1100
Advisory panel: Orthopedic
Date received: 1992-05-06
Decision date: 1992-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Reno, NV, US

Download summary PDF View on FDA.gov ↗

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More clearances from Citation Medical Corp.

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K951941 — CITATION MULTIPLE USE DELTA SCOPE1995-07-14
K945390 — CITATION DELTA SCOPE1995-06-23
K946290 — CITATION POWER TOOL1995-06-15
K951249 — CITATION SINUSCOPE1995-04-10
K944976 — BRONCHOSCOPE,NON-RIGID1994-12-21

Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.